cortizone 10 cooling gel

cortizone 10 cooling gel
SPL v4
SPL
SPL Set ID 14d9fce2-9f54-4204-83cb-161de8a303f0
Route
topical
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
alcohol aloe vera leaf oat dimethicone edetate disodium anhydrous glycerin hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%) isohexadecane maltodextrin menthyl lactate, (-)- methyl gluceth-20 methylparaben polysorbate 60 ppg-3 benzyl ether myristate propylparaben sodium citrate, unspecified form water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-01-01

Purpose

Anti-itch

Description

Cortizone 10 Cooling Gel Drug Facts


Medication Information

Warnings

For external use only

Purpose

Anti-itch

Directions

■ for itching of skin irritation, inflammation, and rashes:  

      ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

      ■  children under 2 years of age: ask a doctor

■   for external anal and genital itching, adults:

      ■  when practical, clean the affected area with mild soap and warm water and rinse thoroughly

      ■  gently dry by patting or blotting with toilet tissue or a soft cloth before applying

      ■ apply to affected area not more than 3 to 4 times daily

      ■ children under 12 years of age: ask a doctor

Description

Cortizone 10 Cooling Gel Drug Facts

Principal Display Panel

MA X IMUM STRENGTH

Cortizone 10


COOLING

ITCH RELIEF GEL


1% Hydrocortisone


Anti-Itch Gel

Net wt 1 oz (28 g)

In

alcohol denat. (15%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, sodium citrate, water

Use

■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:  

     ■ eczema ■  psoriasis    ■ poison ivy, oak, sumac  ■  insect bites ■  detergents ■  jewelry   ■  cosmetics

     ■  soaps ■  seborrheic dermatitis

■  temporarily relieves external anal and genital itching

■  other uses of this product should only be under the advice and supervision of a doctor

Section 42229-5

Cortizone 10

Cooling Gel

Drug Facts

Do Not Use

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

Active Ingredient

Hydrocortisone 1%

When Using This Product

■ avoid contact with eyes  ■ do not use more than directed unless told to do so by a doctor ■  do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

■ rectal bleeding occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Purpose

Anti-itch

Directions

■ for itching of skin irritation, inflammation, and rashes:  

      ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

      ■  children under 2 years of age: ask a doctor

■   for external anal and genital itching, adults:

      ■  when practical, clean the affected area with mild soap and warm water and rinse thoroughly

      ■  gently dry by patting or blotting with toilet tissue or a soft cloth before applying

      ■ apply to affected area not more than 3 to 4 times daily

      ■ children under 12 years of age: ask a doctor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MA X IMUM STRENGTH

Cortizone 10


COOLING

ITCH RELIEF GEL


1% Hydrocortisone


Anti-Itch Gel

Net wt 1 oz (28 g)

In

alcohol denat. (15%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, sodium citrate, water

Use

■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:  

     ■ eczema ■  psoriasis    ■ poison ivy, oak, sumac  ■  insect bites ■  detergents ■  jewelry   ■  cosmetics

     ■  soaps ■  seborrheic dermatitis

■  temporarily relieves external anal and genital itching

■  other uses of this product should only be under the advice and supervision of a doctor

Section 42229-5 (42229-5)

Cortizone 10

Cooling Gel

Drug Facts

Do Not Use (Do not use)

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

When Using This Product (When using this product)

■ avoid contact with eyes  ■ do not use more than directed unless told to do so by a doctor ■  do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

■ rectal bleeding occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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